MAUDE Adverse Event Report: BIOMERIEUX INC. VITEK® 2 YST TEST KIT

Catalog Number	21343
Medical Device Problem Code	Incorrect Or Inadequate Test Results (2456)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Event or Problem Description
A customer in the united states reported a misidentification of a candida guilliermondii cap survey sample (f1-02), as candida famata in association with the vitek® 2 yst test kit.The customer reported candida famata as their identification.Repeat testing gave a result of low discrimination between c.Guillermondii and c.Famata.The customer submitted the lab and the cap survey reports for evaluation.A biomérieux internal investigation will be initiated.
Additional Manufacturer Narrative
An internal biomérieux investigation was performed.A united states customer obtained an incorrect identification when testing cap survey isolate f1-02 2018 on vitek 2 yst cards.The expected identification is candida guilliermondii; however, the customer obtained an excellent identification of candida famata.On a second run, the customer obtained a low discrimination call of c.Famata/c.Guilliermondii.Therefore, the customer reported c.Famata as their final answer.It should be noted that both c.Guilliermondii and c.Famata/c.Guilliermondii were acceptable answers; however, c.Famata alone was not.Both the customer submitted strain and the internal cap survey strain were subbed and tested on the customer lot and a random lot of vitek 2 yst cards, in duplicate.Api® 20c aux and vitek® ms were also performed.Customer submitted strain (911598): on all four (4) cards tested, a low discrimination call of c.Famata/c.Guilliermondii was obtained.Api 20c aux gave a very good id (99.7%) of c.Guilliermondii and vitek ms gave an identification of c.Guilliermondii, with a 99.9% confidence level.Since c.Guilliermondii was part of the low discrimination call on all cards tested, cards are performing as expected for this organism.Internal survey strain (911599): a low discrimination call of c.Famata/c.Guilliermondii was obtained on one (1) card from the customer lot and one (1) card from the random lot.An excellent id of c.Famata was obtained on one (1) card from the customer lot and one (1) card from the random lot.Api 20c aux gave a very good id (99.7%) of c.Guilliermondii and vitek ms gave an identification of c.Guilliermondii, with a 99.9% confidence level.A comparison of card reaction results against expected reaction results for c.Guilliermondii revealed one (1) atypical negative reaction (dgata) that led to the incorrect call.Conclusion: atypical strain a complaint history review was completed for this issue during the last 13 month timeframe with no implication of a trend.The most recent quarterly trend review did not identify this complaint as a systemic quality issue.

• Brand Name: VITEK® 2 YST TEST KIT
• Common Device Name: VITEK® 2 YST TEST KIT
• Manufacturer (Section D): BIOMERIEUX INC.; 595 anglum road; st. louis MO 63042
• MDR Report Key: 7558261
• Report Number: 1950204-2018-00201
• Device Sequence Number: 16553642
• Product Code: JXB
• UDI-Device Identifier: 03573026131937
• UDI-Public: 03573026131937
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: C1 EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/09/2019
• Device Catalogue Number: 21343
• Device Lot Number: 2430590203
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2018
• Supplement Date Received by Manufacturer: 06/12/2018
• Initial Report FDA Received Date: 05/31/2018
• Supplement Report FDA Received Date: 07/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1